Soft oral product

ABSTRACT

An oral product includes a body that is wholly receivable in an oral cavity. The body includes a polymer matrix and one or more flavorants and/or active ingredients embedded in the polymer matrix. The polymer matrix can include a copolymer of ethylene and one or more vinyl monomers or zein. For example, the polymer can be ethylene-vinyl acetate copolymer and/or ethylene-vinyl alcohol copolymer. In some cases, the oral product can include tobacco and/or nicotine.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a Divisional application of, and claims the benefitof priority under 35 U.S.C. §121 to, U.S. application Ser. No.14/206,541 filed Mar. 12, 2014, which claims the benefit of priorityunder 35 U.S.C. §119(e) to U.S. Application No. 61/786,195 filed Mar.14, 2013.

The prior applications are incorporated herein by reference in theirentirety.

TECHNICAL FIELD

This document relates to soft oral products including certain polymersand one or more flavors and/or active ingredients. In some case, thepolymer can be ethylene vinyl acetate copolymer, ethylene vinyl alcoholcopolymer, zein, gelatin, or a combination thereof. In some cases, thesoft oral product can include tobacco.

BACKGROUND

Tobacco compositions are available to adult tobacco consumers in avariety of forms. Smoking tobacco is combusted and the aerosol eithertasted or inhaled (e.g., in a cigarette, cigar, or pipe). Smokelesstobacco products are not combusted and include: chewing tobacco, moistsmokeless tobacco, snus, and dry snuff. Chewing tobacco is coarselydivided tobacco leaf that is typically packaged in a large pouch-likepackage and used in a plug or twist. Moist smokeless tobacco is a moist,more finely divided tobacco that is provided in loose form or in pouchform and is typically packaged in round cans and used as a pinch or in apouch placed between acheek and gum of an adult tobacco consumer. Snusis a heat treated smokeless tobacco. Dry snuff is finely ground tobaccothat is placed in the mouth or used nasally.

SUMMARY

This document describes an oral product that provides a satisfyingtactile and/or flavor experience. The oral product includes a body thatis at least partially receivable in an oral cavity of an adult consumer.In some cases, the body includes a polymer matrix of a copolymer ofethylene and a vinyl monomer. In some cases, the body includes a matrixof zein. In some cases, the body includes a matrix of gelatin. In somecases, the body includes a matrix including a combination of acopolymer, zein, and/or gelatin. In some cases, the matrix can includeone or more flavors and/or active ingredients. For example, the matrixcan include tobacco.

The oral products provided herein can optionally include one or more ofthe following features. In some cases, the body of the oral productincludes at least 10 weight percent of the copolymer, the zein, and/orthe gelatin. The copolymer can be a random copolymer. In some cases, thecopolymer can be a block copolymer. In some cases, the copolymer caninclude ethylene and vinyl acetate. In some cases, the copolymer caninclude ethylene and vinyl alcohol. In some cases, the copolymerincludes between 25 percent by weight and 40 percent by weight vinylmonomers. The oral product provided herein can include a plasticizerand/or a surfactant dispersed in the mouth-stable polymer matrix. Forexample, the plasticizer can be propylene glycol, glycerin, vegetableoil, triglycerides, or a combination thereof. The oral product can alsoinclude a sweetener dispersed in the body. The sweetener can besaccharine, sucralose, aspartame, acesulfame potassium, or a combinationthereof.

The oral product, according to certain embodiments, includes one or moreadditives. For example, the oral product can include an additiveselected from the group consisting of minerals, vitamins, dietarysupplements, nutraceuticals, energizing agents, soothing agents, aminoacids, chemesthesis agents, antioxidants, botanicals, teeth whiteningagents, therapeutic agents, or a combination thereof.

The body of the oral product can have at least 10 weight percentcelluloid fibers. In some cases, the celluloid fibers can includetobacco fibers. In some cases, the oral product can include non-tobaccocelluloid fibers. For example, the celluloid fibers can be selected fromthe following: sugar beet fiber, wood pulp fiber, cotton fiber, branfiber, citrus pulp fiber, grass fiber, willow fiber, poplar fiber, andcombinations thereof. The non-tobacco celluloid fibers may also bechemically treated prior to use. For example, the non-tobacco celluloidfibers can be CMC, HPMC, HPC, or other treated cellulosic material.

The oral product can include flavorants. The flavorants can be naturalor artificial. Flavorants can be selected from the following: licorice,wintergreen, cherry and berry type flavorants, Drambuie, bourbon,scotch, whiskey, spearmint, peppermint, lavender, cinnamon, cardamon,apium graveolents, clove, cascarilla, nutmeg, sandalwood, bergamot,geranium, honey essence, rose oil, vanilla, lemon oil, orange oil,Japanese mint, cassia, caraway, cognac, jasmin, chamomile, menthol,ylangylang, sage, fennel, piment, ginger, anise, coriander, coffee, mintoils from a species of the genus Mentha, cocoa, and combinationsthereof. Synthetic flavorants can also be used. The particularcombination of flavorants can be selected from the flavorants that aregenerally recognized as safe (“GRAS”) in a particular country, such asthe United States. Flavorants can also be included in the oral productas encapsulated flavorants.

The body of the oral product can have a variety of different shapes,some of which include disk, shield, rectangle, and square. According tocertain embodiments, the body can have a length or width of between 5 mmand 25 mm and a thickness of between 1 mm and 10 mm.

The body of the oral product can be compressible and springy. In somecases, the body can return to an original shape after being deformed byan adult consumer using a chewing action. As the oral product is workedto release flavors and/or active ingredients, the oral product canbecome flatter, yet still retain some shape memory, unlike a chewinggum. In some cases, the oral product can have chewing gum-like chewingproperties, yet not be sticky.

In general, another aspect of the subject matter described in thisspecification is methods of making and using the oral product. Themethods of making the oral product can include the actions of extrudinga mouth-stable polymer having tobacco fibers dispersed therein.

The details of one or more embodiments of the subject matter describedin this specification are set forth in the accompanying drawings and thedescription below. Other features, aspects, and advantages of thesubject matter will become apparent from the description, the drawings,and the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a pair of oral products.

FIGS. 2A-2O illustrate various exemplary shapes of oral products.

FIG. 3A-3J illustrate oral products having various rod, stick, or tubeconfigurations.

DETAILED DESCRIPTION

The oral products described herein include a polymer matrix and one ormore flavorants and/or active ingredients embedded therein. The polymermatrix can include a copolymer of ethylene and a vinyl monomer (e.g.,ethylene-vinyl acetate or ethylene-vinyl alcohol). In some cases, thepolymer matrix can include zein. In some cases, the polymer matrix caninclude gelatin. In some cases, the oral products described herein caninclude tobacco and can provide a favorable tobacco experience.

The oral product can include ethylene-vinyl acetate copolymer.Ethylene-vinyl acetate copolymer can have properties that approach theproperties of elastomeric materials in softness and flexibility, yet canbe processed like other thermoplastics. In some cases, theethylene-vinyl acetate copolymer can be a random copolymer. In somecases, the ethylene-vinyl acetate copolymer can include between 25% byweight and 40% by weight of vinyl acetate. A higher percentage of vinylacetate can increase the softness of the ethylene-vinyl acetatecopolymer. In some cases, the ethylene-vinyl acetate copolymer isamorphous. In some cases, the oral product can include nicotine.Nicotine can bind to the vinyl acetate groups and held slow a release ofnicotine into a mouth of an adult consumer during use. Theethylene-vinyl acetate copolymer can be shaped (e.g., extruded) at atemperature of about 100° C., thus it can be mixed and shaped withflavorants and/or active ingredients that might volatize or degrade ifheated to higher temperatures.

The oral product can include ethylene-vinyl alcohol copolymer.Ethylene-vinyl alcohol copolymer can be prepared by polymerization ofethylene and vinyl acetate to give the ethylene-vinyl acetate copolymerfollowed by hydrolysis to convert the vinyl acetate units into vinylalcohol units. In some cases, the ethylene-vinyl alcohol copolymer canbe a random copolymer. In some cases, the ethylene-vinyl alcoholcopolymer can include between 25% by weight and 40% by weight of vinylalcohol. In some cases, the ethylene-vinyl acetate copolymer isamorphous. The ethylene-vinyl alcohol copolymer can be shaped (e.g.,extruded) at a temperature of 100° C. or less, thus it can be mixed andshaped with flavorants and/or active ingredients that might volatize ordegrade if heated to higher temperatures. In some cases, the polymer caninclude a mixture of ethylene-vinyl alcohol copolymer and ethylene-vinylacetate copolymer.

In some cases, the oral product can include zein as a matrix for holdingtobacco. Zein is a class of prolamine protein. In some cases, the zeincan be corn zein, which is found in maize. Zein is clear, odorless,tasteless, water-insoluble, and edible.

In some cases, the oral product can include gelatin as a matrix forholding tobacco. Gelatin is a mixture of peptides and proteins producedby partial hydrolysis of collagen extracted from, for example, the skin,boiled crushed horn, hoof and bones, connective tissues, organs and someintestines of animals such as domesticated cattle, chicken, pigs, andhorses. The natural molecular bonds between individual collagen strandsare broken down into a form that rearranges more easily. Gelatin meltsto a liquid when heated and solidifies when cooled again. Together withwater, it can form a semi-solid colloid gel.

The polymer matrix can be mouth stable. As used here, the term “mouthstable” means that the polymer does not appreciably dissolve ordisintegrate when exposed to saliva within an oral cavity and at thenormal human body temperature (e.g., about 98.6° F.) over a period ofone hour. In some cases, the oral products described herein can remainintact when placed within an oral cavity during a use period. After use,the mouth-stable polymer matrix can be removed from the oral cavity anddiscarded.

One or more additives are included in the oral product and adapted to bereleased from the oral product when the oral product is placed in anoral cavity. The oral product, in some cases, includes added nicotineand/or other additives. Celluloid fibers can help to provide access tonicotine and/or other additives throughout the oral product. During use,saliva can be absorbed into the polymer matrix to release the nicotineand/or other additives. In some cases, the oral product can includetobacco (e.g., tobacco fibers). The absorbed saliva can cause thecelluloid fibers (e.g., tobacco fibers and/or non-tobacco fibers) toexpand, which can facilitate further release of tobacco constituents,additives, sweeteners, and/or flavorants. Mechanical action (e.g.,chewing) of the oral product can facilitate the release of theadditives, sweeteners, and/or flavorants.

In addition to additives, sweeteners, and flavorants, the oral productcan also include fillers, plasticizers, and/or processing aids. Fillerscan also be included in the polymer matrix to alter the texture orpliability of the oral product. For example, starch deposits can beincluded and designed to be crushed during the chewing of the oralproduct. The polymer matrix can also include surfactants and/orplasticizers, which can increase the softness of the oral product.Processing aids can also be present in the oral product and be used tofacilitate shaping processes.

Oral Product Shapes and Packaging

FIG. 1 depicts an example of an oral product 110. The oral product 110has a disk shape. For example, the oral product 110 can have a diameterof about 12 mm and a thickness of about 2.5 mm.

Referring now to FIGS. 2A-2N, the oral product 110 can be molded intoany desired shape. For example, referring to FIGS. 2A-2L, the oralproduct 110A-L can be formed in a shape that promotes improved oralpositioning in the oral cavity, improved packaging characteristics, orboth. In some circumstances, the oral product 110A-L can be configuredto be: (A) an elliptical-shaped oral product 110A ; (B) an elongatedelliptical-shaped oral product 110B; (C) semi-circular oral product110C; (D) square or rectangular-shaped oral product 110D; (E)football-shaped oral product 110E; (F) elongated rectangular-shaped oralproduct 110F; (G) boomerang-shaped oral product 110G; (H) rounded-edgerectangular-shaped oral product 110H; (I) teardrop- or comma-shaped oralproduct 110I; (J) bowtie-shaped oral product 110J; (K) peanut-shapedoral product 110K; and (L) shield-shaped oral product. Alternatively,the oral product can have different thicknesses or dimensionality, suchthat a beveled article (e.g., a wedge) is produced (see, for example,product 110M depicted in FIG. 2M) or a hemi-spherical shape is produced.In some cases, the oral product has a shield shape.

In addition or in the alternative to flavorants being included withinthe mouth-stable polymer matrix, flavorants can be included on anexterior of the oral product 110. For example, referring to FIG. 2N, forexample, some embodiments of an oral product 110N can be equipped withflavor strips 116.

Referring to FIG. 2O, particular embodiments of the oral product 110 canbe embossed or stamped with a design (e.g., a logo, an image, or thelike). For example, the oral product 110O can be embossed or stampedwith any type of design 117 including, but not limited to, a trademark,a product name, or any type of image. The design 117 can be formeddirectly into the oral product, arranged along the exterior of theproduct 110O. The design 117 can also be embossed or stamped into thoseembodiments with a dissolvable film 116 applied thereto.

In some cases, the oral product 110 or products 110A-O can be wrapped orcoated in an edible or dissolvable film, which may be substantiallytransparent or translucent. The dissolvable film can readily dissipatewhen the oral product 110 is placed in an oral cavity.

One or more oral products 110 can be packaged in a variety ofconventional and non-conventional manners. For example, a plurality oforal products 110 can be packaged in a container having a lid. In otherembodiments, a plurality of oral products 110 can be stacked andpackaged in a paper, plastic, and/or aluminum foil tube. The packagingcan have a child-resistant lid.

The oral product 110 can also include additional elements. In somecases, a polymer matrix including one or more flavorants and/or activeingredients (e.g., tobacco fibers) can be attached to a rod, tube, orstick. For example, FIGS. 3A-3J illustrate tubes attached to a polymermatrix tips. FIG. 3A depicts an embodiment of an oral product having atip piece 310 and a tube piece 320. In some cases, the tip piece 310 caninclude the polymer matrix (e.g., ethylene-vinyl acetate copolymer) andtobacco within the polymer matrix. In some cases, the tip piece 310 caninclude the polymer matrix (e.g., ethylene-vinyl acetate copolymer) andnicotine. The tip piece 310 can be sized and shaped to be at leastpartially received in an oral cavity. The tube piece 320 can be made ofany conventional polymer. During use the tube piece 320 can act asholder for the tip piece 310. The tube piece 320 and the tip piece 310can be attached by a snap-fit attachment feature 330, as shown in FIG.3B.

The tube piece 320 can be reusable. For example, multiple tip pieces 310can be packaged with a single tube piece 320 and a user can switch offthe tip pieces 310. In some cases, the tube pieces 320 can be intendedfor a single use. In some cases, the tube pieces 320 can includeflavorants within the tube. The flavorants can be adapted to be releasedwhen air is drawn through the tube 320. For example, FIG. 3C depicts atube including a flavor ribbon 322. FIG. 3D depicts a tube 320 includinga flavor strip 324 and a plurality of flavor beads 326. FIG. 3E depictsa tube 320 including a compressed mass 328 of flavor beads 326. In somecases, the inside of the tube can have structure adapted to alter theflow pattern of air drawn into the tube. For example, FIG. 3F depicts atube 320F having a series of steps and constrictions 340 adapted toalter the flow pattern of air drawn into the tube. FIG. 3F also depictsan alternative connection feature 330F.

FIG. 3G depicts an embodiment having a recorder-like shape. As shown, atip piece 310G is connected to the contoured tube piece 320. Forexample, the recorder-shaped tip 310G can be composed of a mouth-stablepolymer matrix that includes tobacco fibers, one or more sweeteners, andone or more flavorants. As shown, the tip piece 310G is sized and shapedto be at least partially received within an oral cavity of an adulttobacco consumer.

FIG. 3H depicts a similarly shaped oral product having a plasticrecorder-shaped tip 310H that includes a reusable plastic part 312 and amouth-stable polymer matrix part 315 having tobacco fibers dispersedtherein. FIGS. 31 and 3J depict embodiments having alternatively shapedtip pieces 3101 and 310J. FIG. 31 depicts an embodiment having a taperedtube 3201. FIG. 3J depicts an embodiment having vent holes at thenon-tip end of the tube piece 320J.

In some cases, a system or kit of different tubes and rods and/ordifferent tips can be packaged together, each having the same type ofattachment features. Embodiments having each of the combinations of tipsand tubes or rods shown in FIGS. 3A-3J are contemplated.

Oral Product Properties

The oral product 110 can provide a favorable tactile experience (e.g.,mouth feel). The oral product 110 can also retain its shape duringprocessing, shipping, handling, and optionally use. As noted above, theoral product 110 includes a polymer matrix that does not appreciablydissolve or disintegrate when placed in an oral cavity and exposed tosaliva. In some cases, the oral product 110 can have an elasticityallowing an adult tobacco consumer to work the product within the mouth.In some cases, the oral product 110 has at least some shape memory andthus can return to shape after being squeezed between teeth in an oralcavity. Working of the oral product 110 within the oral cavity canaccelerate the release of the flavors, active ingredients, additives,and/or sweeteners within the polymer matrix. For example, nicotineand/or tobacco can be included in a polymer matrix includingethylene-vinyl acetate copolymer.

During use, the oral product 110 can absorb saliva into the polymermatrix. The saliva can cause celluloid fibers in the polymer matrix toswell, which can further increase access to different sections of thepolymer matrix. Physical activity, such as chewing of the oral productin the mouth, can also accelerate the swelling of any celluloid fiberswithin the matrix and therefore the release of additives. Chewing canalso break apart encapsulated ingredients and/or starch deposits withinthe matrix. As the oral product is chewed, saliva can access differentsections of the polymer matrix. The oral product 110 can be chewedwithout significant and instantaneous permanent plastic deformation. Asthe product is chewed, it can become more pliable and additionaladditives can become available for release into the oral cavity. Someembodiments of the oral product 110 can be adapted to remain non-stickyduring and after use. After prolonged use, certain embodiments of theoral product 110 will expand and become flatter. The oral product,however, can retain the essence of its original shape. The amount ofdeformation will depend on the duration of use and an amount of mouthforce used. As the product is used, it can increase in both weight andvolume, due to the swelling. With greater the physical manipulation, theoral product 110 will have a greater amount of swelling and thus have alarger weight gain. In certain embodiments, the oral product 110 willhave an increase in weight of between 4 and 75 percent when chewed by anadult consumer for 30 minutes.

The particular materials used in the oral product 110 and the processingtechniques discussed below can have an impact on the physical propertiesof the oral product. Moreover, the incorporation of air bubbles orchannels, or different fillers and/or fibers can also have an impact onthe elasticity and pliability of the oral product. Additionally, thematerial properties of the overall oral product 110 can change astobacco constituents and/or other ingredients are released. In somecases, non-tobacco fibers and/or fillers can also dissolve ordisintegrate during use and thus alter the material properties of theoral product 110 during use.

The oral product 110 can have a variety of colors. In some cases,natural and artificial coloring can be added to the mouth-stable polymerbefore or during the molding process to form oral products 110 having apredetermined color. Encapsulated flavors can be added during theextrusion process to create speckles, patterns or dots within the oralproduct.

Tobacco

In some cases, the oral product can include tobacco within the polymermatrix. Tobacco can be mixed with the polymer prior to or during anextrusion process. Tobacco fibers can provide passages in the polymermatrix, which can permit certain tobacco constituents and/or additiveswithin the mouth-stable polymer matrix to be released into an oralcavity when the oral product is received in an oral cavity and exposedto saliva.

By “tobacco” it is meant a part, e.g., leaves, and stems, of a member ofthe genus Nicotiana that cut, shredded, or otherwise processed to formfibers of tobacco plant tissue. Exemplary species of tobacco include N.rustica, N. tabacum, N. tomentosiformis, and N. sylvestris. For example,the tobacco fibers can be obtained by comminuting tobacco stems. Thetobacco can include cellulose, lignin, lipids, hemicellulose, and othertobacco constitutents.

Suitable tobaccos include fermented and unfermented tobaccos. Inaddition to fermentation, the tobacco can be processed using othertechniques. For example, tobacco can be processed by heat treatment(e.g., cooking, toasting), flavoring, enzyme treatment, expansion and/orcuring. Both fermented and non-fermented tobaccos can be processed usingthese techniques. In other embodiments, the tobacco can be unprocessedtobacco. Specific examples of suitable processed tobaccos include darkair-cured, dark fire-cured, burley, flue cured, and cigar filler orwrapper, as well as the products from the whole leaf stemming operation.In some cases, the tobacco fibers includes up to 70% dark tobacco on afresh weight basis.

Tobacco can be conditioned by heating, sweating and/or pasteurizingsteps as described in U.S. Publication Nos. 2004/0118422 or2005/0178398. Fermenting typically is characterized by high initialmoisture content, heat generation, and a 10 to 20% loss of dry weight.See, e.g., U.S. Pat. Nos. 4,528,993; 4,660,577; 4,848,373; and5,372,149. In addition to modifying the aroma of the leaf, fermentationcan change either or both the color and texture of a leaf. Also duringthe fermentation process, evolution gases can be produced, oxygen can betaken up, the pH can change, and the amount of water retained canchange. See, for example, U.S. Publication No. 2005/0178398 and Tso(1999, Chapter 1 in Tobacco, Production, Chemistry and Technology, Davis& Nielsen, eds., Blackwell Publishing, Oxford). Cured, or cured andfermented tobacco can be further processed (e.g., cut, expanded,blended, milled or comminuted) prior to incorporation into the oralproduct. The tobacco, in some cases, is long cut fermented cured moisttobacco having an oven volatiles content of between 48 and 50 weightpercent prior to mixing with the copolymer and optionally flavorants andother additives.

The tobacco can, in some cases, be prepared from plants having less than20 μg of DVT per cm² of green leaf tissue. For example, the tobaccofibers can be selected from the tobaccos described in U.S. PatentPublication No. 2008/0209586, which is hereby incorporated by reference.Tobacco compositions containing tobacco from such low-DVT varietiesexhibits improved flavor characteristics in sensory panel evaluationswhen compared to tobacco or tobacco compositions that do not havereduced levels of DVTs.

Green leaf tobacco can be cured using conventional means, e.g.,flue-cured, barn-cured, fire-cured, air-cured or sun-cured. See, forexample, Tso (1999, Chapter 1 in Tobacco, Production, Chemistry andTechnology, Davis & Nielsen, eds., Blackwell Publishing, Oxford) for adescription of different types of curing methods. Cured tobacco isusually aged in a wooden drum (i.e., a hogshead) or cardboard cartons incompressed conditions for several years (e.g., two to five years), at amoisture content ranging from 10% to about 25%. See, U.S. Pat. Nos.4,516,590 and 5,372,149. Cured and aged tobacco then can be furtherprocessed. Further processing includes conditioning the tobacco undervacuum with or without the introduction of steam at varioustemperatures, pasteurization, and fermentation. Fermentation typicallyis characterized by high initial moisture content, heat generation, anda 10 to 20% loss of dry weight. See, e.g., U.S. Pat. Nos. 4,528,993,4,660,577, 4,848,373, 5,372,149; U.S. Publication No. 2005/0178398; andTso (1999, Chapter 1 in Tobacco, Production, Chemistry and Technology,Davis & Nielsen, eds., Blackwell Publishing, Oxford). Cure, aged, andfermented tobacco can be further processed (e.g., cut, shredded,expanded, or blended). See, for example, U.S. Pat. Nos. 4,528,993;4,660,577; and 4,987,907.

The tobacco can be processed to a desired size. In certain cases, thetobacco fiber can be processed to have an average fiber size of lessthan 200 micrometers. In some cases, the tobacco fibers are between 75and 125 micrometers. In other embodiments, the fibers are processed tohave a size of 75 micrometers or less. In some cases, the tobacco fibersincludes long cut tobacco, which can be cut or shredded into widths ofabout 10 cuts/inch up to about 110 cuts/inch and lengths of about 0.1inches up to about 1 inch. Double cut tobacco fibers can have a range ofparticle sizes such that about 70% of the double cut tobacco fibersfalls between the mesh sizes of −20 mesh and 80 mesh. The tobacco canhave a total oven volatiles content of about 10% by weight or greater;about 20% by weight or greater; about 40% by weight or greater; about15% by weight to about 25% by weight; about 20% by weight to about 30%by weight; about 30% by weight to about 50% by weight; about 45% byweight to about 65% by weight; or about 50% by weight to about 60% byweight. Those of skill in the art will appreciate that “moist” tobaccotypically refers to tobacco that has an oven volatiles content ofbetween about 40% by weight and about 60% by weight (e.g., about 45% byweight to about 55% by weight, or about 50% by weight). As used herein,“oven volatiles” are determined by calculating the percentage of weightloss for a sample after drying the sample in a pre-warmed forced draftoven at 110° C. for 3.25 hours. The oral product can have a differentoverall oven volatiles content than the oven volatiles content of thetobacco fibers used to make the oral product. The processing stepsdescribed herein can reduce or increase the oven volatiles content.

Additives

A variety of additives can be included in the oral product 110. Theadditives can include alkaloids (e.g., nicotine), minerals, vitamins,dietary supplements, nutraceuticals, energizing agents, soothing agents,coloring agents, amino acids, chemesthesis agent, antioxidants, foodgrade emulsifiers, pH modifiers, botanicals (e.g., green tea), teethwhitening (e.g., SHRIMP), therapeutic agents, sweeteners, flavorants,and combinations thereof. In certain embodiments, the additives includenicotine, sweeteners, and/or flavorants.

Nicotine

Nicotine added to the oral product can be tobacco-derived nicotine,synthetic nicotine, or a combination thereof. In certain embodiments,the oral product includes between 0.1 mg and 6.0 mg of nicotine. In someof these embodiments, the oral product includes between 1.0 mg and 3.0mg of nicotine. As discussed above, nicotine can bind with the vinylacetate in ethylene-vinyl acetate copolymer to slow the release ofnicotine from an oral product.

Tobacco-derived nicotine includes one or more other tobacco organolepticcomponents other than nicotine. The tobacco-derived nicotine can beextracted from raw (e.g., green leaf) tobacco and/or processed tobacco.Processed tobaccos can include fermented and unfermented tobaccos, darkair-cured, dark fire-cured, burley, flue cured, and cigar filler orwrapper, as well as the products from the whole leaf stemming operation.The tobacco can also be conditioned by heating, sweating and/orpasteurizing steps as described in U.S. Publication Nos. 2004/0118422 or2005/0178398. Fermenting typically is characterized by high initialmoisture content, heat generation, and a 10 to 20% loss of dry weight.See, e.g., U.S. Pat. Nos. 4,528,993; 4,660,577; 4,848,373; and5,372,149. By processing the tobacco prior to extracting nicotine andother organoleptic components, the tobacco-derived nicotine may includeingredients that provide a favorable experience.

The tobacco-derived nicotine can be obtained by mixing cured andfermented tobacco with water or another solvent (e.g., ethanol) followedby removing the insoluble tobacco material. The tobacco extract may befurther concentrated or purified. In some cases, select tobaccoconstituents can be removed. Nicotine can also be extracted from tobaccoin the methods described in the following patents: U.S. Pat. Nos.2,162,738; 3,139,436; 3,396,735; 4,153,063; 4,448,208; and 5,487,792.

The nicotine can also be purchased from commercial sources, whethertobacco-derived or synthetic. In other embodiments, the oral product caninclude a derivative of nicotine (e.g., a salt of nicotine).

Sweeteners

A variety of synthetic and/or natural sweeteners can be used asadditives in the oral product 110. Suitable natural sweeteners includesugars, for example, monosaccharides, disaccharides, and/orpolysaccharide sugars, and/or mixtures of two or more sugars. Accordingto some embodiments, the oral product 110 includes one or more of thefollowing: sucrose or table sugar; honey or a mixture of low molecularweight sugars not including sucrose; glucose or grape sugar or cornsugar or dextrose; molasses; corn sweetener; corn syrup or glucosesyrup; fructose or fruit sugar; lactose or milk sugar; maltose or maltsugar or maltobiose; sorghum syrup; mannitol or manna sugar; sorbitol ord-sorbite or d-sobitol; fruit juice concentrate; and/or mixtures orblends of one or more of these ingredients. The oral product 110 canalso include non-nutritive sweeteners. Suitable non-nutritive sweetenersinclude: stevia, saccharin; Aspartame; sucralose; or acesulfamepotassium.

Flavorants

The oral product 110 can optionally include one or more flavorants. Theflavorants can be natural or artificial. For example, suitableflavorants include wintergreen, cherry and berry type flavorants,various liqueurs and liquors (such as Dramboui, bourbon, scotch, andwhiskey) spearmint, peppermint, lavender, cinnamon, cardamon, apiumgraveolents, clove, cascarilla, nutmeg, sandalwood, bergamot, geranium,honey essence, rose oil, vanilla, lemon oil, orange oil, Japanese mint,cassia, caraway, cognac, jasmin, chamomile, menthol, ylangylang, sage,fennel, piment, ginger, anise, coriander, coffee, liquorish, and mintoils from a species of the genus Mentha, and encapsulated flavors. Mintoils useful in particular embodiments of the oral product 110 includespearmint and peppermint. Synthetic flavorants can also be used. Theparticular combination of flavorants can be selected from the flavorantsthat are generally recognized as safe (“GRAS”) in a particular country,such as the United States. Flavorants can also be included in the oralproduct as encapsulated flavorants.

In some cases, the flavorants in the oral product 110 are limited toless than 20 weight percent in sum. In some cases, the flavorants in theoral product 110 are limited to be less than 10 weight percent in sum.For example, certain flavorants can be included in the oral product 110in amounts of about 1 weight percent to 5 weight percent.

Other Additives

The oral product 110 may optionally include other additives. Forexample, these additives can include non-nicotine alkaloids, vitamins,dietary minerals, other dietary supplements, and/or therapeutic agents.For example, suitable vitamins include vitamins A, B1, B2, B6, C, D2,D3, E, F, K, and P. For example, an oral product 110 can includeC-vitamins. Suitable dietary minerals include calcium (as carbonate,citrate, etc.) or magnesium (as oxide, etc.), chromium (usually aspicolinate), and iron (as bis-glycinate). One or more dietary mineralscould be included in an oral product with or without the use of otheradditives. Other dietary supplements and/or therapeutic agents can alsobe included as additives.

The oral product 110 can also include fillers such as starch, di-calciumphosphate, lactose, sorbitol, mannitol, and microcrystalline cellulose,calcium carbonate, dicalcium phosphate, calcium sulfate, clays, silica,glass particles, sodium lauryl sulfate (SLS), glyceryl palmitostearate,sodium benzoate, sodium stearyl fumarate, talc, and stearates (e.g., Mgor K), and waxes (e.g., glycerol monostearate, propylene glycolmonostearate, and acetylated monoglycerides), stabilizers (e.g.,ascorbic acid and monosterol citrate, BHT, or BHA), disintegratingagents (e.g., starch, sodium starch glycolate, cross caramellose, crosslinked PVP), pH stabilizers, or preservatives. In some cases, the amountof filler in the oral product 110 is limited to less than 10 weightpercent in sum. In some cases, the amount of filler in the oral product110 is limited to be less than 5 weight percent in sum. In some cases,the fillers are mouth stable. In some cases, the fillers can dissolve ordisintegrate during use and thus result in an oral product that becomesmore pliable during use. In some cases, the filler can be crisped riceand/or encapsulated ingredients, which can break when the oral productis chewed.

Non-Tobacco Fibers

The oral product can further include non-tobacco fibers within thepolymer matrix. In some cases, the non-tobacco fibers are hydrophilicsuch that water-soluble additives can be wicked by the fibers. In somecases, the fibers can dissolve to leave channels.

The non-tobacco fibers can be non-tobacco celluloid fibers. Thenon-tobacco celluloid fibers can be derived from plant tissue. In somecases, the non-tobacco celluloid fibers includes cellulose. Thenon-tobacco celluloid fibers can further include lignin and/or lipids.Suitable sources for non-tobacco celluloid fibers include wood pulp,cotton, sugar beets, bran, citrus pulp fiber, switch grass and othergrasses, Salix (willow), tea, and Populus (poplar). In some cases, thenon-tobacco celluloid fibers can be plant tissue comprising variousnatural flavors, sweeteners, or active ingredients. In some cases, theoral product 110 can include nicotine as an additive (optionally withadditional sweeteners and flavors) and a combination of both non-tobaccocellulosic fiber and tobacco fiber. In some alternative embodiments,additional cellulosic fiber can be derived from tobacco plant tissue(e.g., exhausted tobacco fibers).

The oral product 110 can also include soluble fibers. The soluble fiberscan be adapted to dissolve when exposed to saliva when the oral product110 is received in an oral cavity. Soluble fibers can be used withtobacco fibers to provide channels for additives to be released from theoral product. As the soluble fibers dissolve, the oral product 110 canbecome more flexible and the additional channels can open up to permitthe release of additional tobacco constituents and/or additives.Suitable soluble fibers include psyllium fibers.

Plasticizers

The oral product 110 can also include one or more plasticizers.Plasticizers can soften the final oral product and thus increase itsflexibility. Plasticizers work by embedding themselves between thechains of polymers, spacing them apart (increasing the “free volume”),and thus significantly lowering the glass transition temperature for theplastic and making it softer. Suitable plasticizers include propyleneglycol, glycerin, vegetable oil, and medium chain triglycerides. In somecases, the plasticizer can include phthalates. Esters of polycarboxylicacids with linear or branched aliphatic alcohols of moderate chainlength can also be used as plasticizers. Moreover, plasticizers canfacilitate the extrusion processes described below. In some cases, theoral product 110 can include up to 20 weight percent plasticizer. Insome cases, the oral product 110 includes between 0.5 and 10 weightpercent plasticizer, the oral product 110 can include between 1 and 8weight percent plasticizer, or between 2 and 4 weight percentplasticizer. For example, an oral product can include about 3 to 6.5weight percent of propylene glycol.

Molding Processes

The oral product 110 can be produced by extruding a mouth-stable polymerwith tobacco fibers to form a rod of a mouth-stable polymer matrixincluding tobacco fibers. The rod is cut into individual oral products.For example, ethylene-vinyl acetate copolymer can be introduced into anextruder along with tobacco fibers. A mixture of optional additives canalso be introduced into the extruder. For example, the additives caninclude a surfactant and a sweetener (e.g., sucralose). The mixture ofadditives can be provided in slurry form or a dry mix of powderedadditives. A first section of the extruder can melt and mix theethylene-vinyl acetate copolymer at a temperature of about 100° C. Thetobacco, surfactant and sweetener can then be added while theethylene-vinyl acetate copolymer is maintained in a melted state. Themixture can then be extruded out of an extrusion die at a temperature ofabout 100° C.

The polymer matrix/tobacco composite can exit an extrusion die as a rodonto a moving conveyor. The extruded polymer-tobacco rod can then cut ina cutting process. The cutting can be hot-face cutting. Hot-face cuttingcan occur immediately after the rod exits the extrusion die. The cuttingprocess can also include a process of rounding the edges of the cutpolymer-tobacco composite. For example, a pelletizer can be used toround the edges. The pelletizer can also help to cool the oral products110. In some cases, the extruded polymer-tobacco rod can be cooled priorto cutting. Before or after cutting, additional additives and/orflavorants can be added to the extruded polymer-tobacco composite.

In addition to the methods described above, there are many methods formaking and shaping the oral products. In some cases, extruded and cutpieces can be introduced into a compression mold to form a final oralproduct shape. In some cases, the oral products 110 can be injectionmolded, compression molded, or injection-compression molded. Blocks ofpolymer and tobacco (and optionally other additives) can also be formedand machined into a desired shape.

Other Embodiments

It is to be understood that, while the invention has been describedherein in conjunction with a number of different aspects, the foregoingdescription of the various aspects is intended to illustrate and notlimit the scope of the invention, which is defined by the scope of theappended claims. Other aspects, advantages, and modifications are withinthe scope of the following claims.

Disclosed are methods and compositions that can be used for, can be usedin conjunction with, can be used in preparation for, or are products ofthe disclosed methods and compositions. These and other materials aredisclosed herein, and it is understood that combinations, subsets,interactions, groups, etc. of these methods and compositions aredisclosed. That is, while specific reference to each various individualand collective combinations and permutations of these compositions andmethods may not be explicitly disclosed, each is specificallycontemplated and described herein. For example, if a particularcomposition of matter or a particular method is disclosed and discussedand a number of compositions or methods are discussed, each and everycombination and permutation of the compositions and the methods arespecifically contemplated unless specifically indicated to the contrary.Likewise, any subset or combination of these is also specificallycontemplated and disclosed.

What is claimed is:
 1. An oral product, comprising a body that is whollyreceivable in an oral cavity, the body comprising: a polymer matrixcomprising a copolymer of ethylene and one or more vinyl monomers; andone or more flavors or active ingredients dispersed in the polymermatrix.